Examination device

ABSTRACT

An examination device for examining the interior of a body cavity has a tubular probe having a first, forward end and a second, rearward end. The probe is mounted in a hand piece, and a closure is engaged with the second end of the probe. A shield is provided on the probe either adjacent the first end or spaced therefrom but forwardly of the hand piece to shield the hand piece from contact with body tissue. The shield is also able to seal against a body orifice.

This application is the national phase under 35 U.S.C. §371 of PCTInternational Application No. PCT/AU99/00902 which has an Internationalfiling date of Oct. 20, 1999, which designated the United States ofAmerica and was published in English.

TECHNICAL FIELD

This invention relates to examination devices of the kind used byphysicians to examine the interiors of body cavities and/or the orificesthereof and to facilitate surgical operations within the body cavities.In particular the present invention is described with reference to anexamination device for use in relation to the vagina.

BACKGROUND ART

There are a number of ways in which physicians routinely examine theinterior of the vagina. One such method is to employ a known dilatingspeculum comprising a tubular array of two or more rigid, elongateleaves, which are inserted into the vagina of a patient and expanded ina radially outward direction to open the vagina for inspection. Whenprior known speculums have been used to admit pressurised fluid forexpanding a body cavity having an external orifice, such as the vagina,it has been usual to tolerate the escape of some of the fluid, usuallyair but sometimes liquid, even though this is unpleasant for theoperator and increases the messiness of the operation. Proposals toalleviate the disabilities flowing from the escape of fluid haveincluded the use of inflatable sealing elements encircling a part of thetubular probe within the body cavity but near the orifice thereof. Thishas not always been effective and invariably obstructs the view of thecavity surface contacted by the sealing element. Furthermore, theprovision of such sealing elements and the means to inflate them havematerially increased the cost of the disposable, so called throw away,tubular probe.

Colposcopes are routinely employed by physicians to examine the interiorof the vagina through such a speculum. Colposcopes typically comprise abinocular microscope and an illuminating unit which allows the physicianto examine the vagina. In many instances the colposcope is a bulky andexpensive instrument set on a stand at approximately 300 mm away fromthe vagina, and as a result of the magnification provided by themicroscope the physician is able to conduct a close up examination. Asthe colposcope is bulky and requires a relatively large stand capable ofsupporting it, it is difficult for the physician to work in close to thearea being examined, particularly when taking pap smears and/orconducting minor surgery.

Germany Patent Specification No. DE4404253 discloses an exploratorydevice which includes a sealing plug having feed through ducts for aninstrument and connection ducts for a suction connection or an airsupply connection to enable gas to pass into or out of the body cavity.A feature of the plug is the provision of an aspirator integral with theplug for controlled removal of gases from the body cavity being. Withsuch an arrangement, sterilisation is difficult and an additional,inflatable seal is preferred which has the disadvantages to whichreference has previously been made.

U.S. Pat. No. 3,817,251 discloses a cannula for laparoscopy whichincludes a cone shaped sleeve adapted to block the incisional gap. Withthis arrangement, the sleeve is formed of stainless steel or a chromeplated steel and is used for surgical treatment where an incision ismade into the abdominal wall. This structure is totally unsuitable foruse in examining the interiors of body cavities and would be difficultto seal against the cavity opening.

U.S. Pat. No. 4,258,721 relates to a hysteroscope which includes acannula for insufflation of a fluid, such as carbon dioxide, inside theuterine cavity. The cannula is combined with an element which abuts thecervix of the uterus. However, the shape of the abutting element is suchthat a substantial part thereof is engaged within the opening thuspreventing examination of the tissue adjacent thereto.

It is therefore desirable to provide an improved examination devicewhich obviates at least some of the disadvantages of prior examinationdevices and which, in addition, is relatively simple and economical tomanufacture and use.

It is also desirable to provide an examination device which is simple touse up close to a body cavity being examined, and through which biopsysamples may be obtained and surgery may be conducted with greaterfacility than heretofore.

SUMMARY OF INVENTION

In one aspect the present invention comprises an examination device foruse in examining the interior of a body cavity, said device including anelongate tubular member having a first end and a second end, a handpiece having a bore there through, and a closure means including aneye-piece, the elongate tubular member being detachably fitted withinthe bore of the hand piece and the closure means being secured to thesecond end of the tubular member to provide a line of sight extendingthrough the closure means and along the bore of the tubular ember, andthe tubular member having a shield means which extends radiallyoutwardly way from the tubular member for preventing contact of the handpiece and closure means with tissue surrounding the body cavity beingexamined.

In an embodiment of the invention, the shield means comprises an annularmember removably engaged with the tubular probe to extend substantiallyradially therefrom. The diameter of the shield means is such that afront surface portion is able to contact tissue surrounding the openingof the body cavity being examined in such a way as to seal against theegress of fluid from the body cavity.

Preferably, the hand piece includes a light source from which light maybe transmitted through the tubular probe, which, in this embodiment, isof a material capable of transmitting light.

In another embodiment the shield means is a cup or dome shaped memberwhich, in use, is adapted to overlie and partially surround at least apart of the hand piece. The cup or dome shaped shield member has a baseportion by which the shield member is engaged with the tubular probe.The base portion has an outer surface adapted to engage and seal withtissue surrounding the opening of the body cavity. One or more annularribs or like surface deformations may be formed in the outer surface ofthe base portion to enhance the sealing with the surrounding tissue.

Embodiments of the invention may provide means for admission of apressurised fluid into the bore of said tubular probe for expanding thebody cavity. In such embodiments, the closure means is provided with aself-sealing aperture for the insertion through the tubular probe andinto the expanded body cavity of surgical instruments, such ascatheters, tissue sample extractors, cauterising devices and the like.The shield means of the present invention facilitates the use of suchdevices by reducing the escape of fluid from the expanded body cavityduring the examination and subsequent procedure.

In a further embodiment of the present invention, the shield meanscomprises a disposable, annular shield sealingly engaged with thetubular probe and extending radially therefrom. The shield is configuredand dimensioned to provide a surface portion of substantial area tocontact an area of body tissue surrounding the orifice of the bodycavity to be examined. The shield is formed of a resilient deformablematerial and may be provided with one or more annular ribs or the liketo enhance sealing contact with the body tissue. The shield may be ofdisc shaped, dome or cup shaped or bell shaped so as to partially fitwithin the orifice of the body cavity whilst having a side wall whichshields the hand piece. By forming the shield of a resilient, deformablematerial, use of the shield does not result in discomfort to the patientand provides a degree of movement of the tubular probe by an operator asthe probe is directed towards different parts of the internal cavitysurface to be examined or treated, without losing sealing efficiency ofthe shield. Further, the resilient, deformable shield is easily andquickly assembled with a tubular probe in a sealing manner and in a waywhich ensures that the shield is retained in place on the tubular probeand effects a fluid seal with the probe.

In one form of the invention, the tubular probe is provided with acircumferential abutment on an external surface thereof a predetermineddistance from is first end. The shield, which has a substantiallycentrally located opening therein, is a sliding, interference fit withthe first end of the tubular probe and abuts the circumferentialabutment to locate the shield axially along the tubular probe andproviding an increased sealing effect between the surfaces of the shieldand the tubular probe. In a particular form of the invention, the shieldis moulded from a closed cell, resilient plastics foam material or iscut or stamped or otherwise formed from a sheet of such material. Asuitable synthetic plastics material includes polyethylene but may alsoinclude any other plastics material capable of forming a resilientclosed cell body having smooth external surfaces which are impervious togas or liquid penetration and which is resistant to chemical reactionwith body fluids, sterilising fluids, antiseptics and the like. In analternative arrangement, the shield may be formed of two or morematerials, such as a relatively rigid backing piece having a resilientsealing layer associated therewith.

DESCRIPTION OF THE DRAWINGS

Embodiments of the invention are described in more detail hereinafterwith reference to the accompanying drawings.

FIG. 1 is an elevational view incorporating a partial sectional view ofa first embodiment of the examination device of the present invention.

FIG. 2 is an elevational view incorporating a partial longitudinalsectional view of the closure means of the device shown in FIG. 1.

FIG. 3 is a front end view of the closure means shown in FIG. 2.

FIG. 4 is an rear end view of the closure means shown in FIG. 2.

FIG. 5 is an elevational view of an elongate tubular probe of the deviceshown in FIG. 1 incorporating a shield according to the invention.

FIG. 6 is a longitudinal sectional view of the tubular probe shown inFIG. 5.

FIG. 7 is a front end view of the tubular probe shown in FIG. 5.

FIG. 8 is a rear end view of the tubular probe shown in FIG. 5.

FIG. 9 is an elevational view incorporating a partial sectional view ofa second embodiment of an examination device of the present invention.

FIG. 10 is an elevational view incorporating a partial sectional view ofa third embodiment of an examination device of the present invention.

FIG. 11 is an elevational view incorporating a partial sectional view ofa fourth embodiment of an examination device of the present invention.

FIG. 12 is an enlarged cross sectional view of the tubular probe andshield means depicted in FIG. 11.

FIG. 13 is an enlarged end view of tubular probe and shield means shownin FIG. 12.

FIG. 14 is an enlarged elevational view of the tubular probe of thesecond embodiment of the examination device shown in FIG. 9. FIG. 15 isa cross-sectional view of the tubular probe shown in FIG. 14.

FIG. 16 is an end view of the tubular probe shown in FIG. 14.

FIG. 17 is an enlarged elevational view of the tubular probe of thethird embodiment of the examination device shown in FIG. 10.

FIG. 18 is a cross-sectional view of the tubular probe shown in FIG. 17.

FIG. 19 is an end view of the tubular probe shown in FIG. 17.

FIG. 20 is an enlarged cross-sectional view of the shield means shown inFIGS. 9, 10 and 11.

FIG. 21 is a front end view of the shield means shown in FIG. 20.

FIG. 22 is a rear end view of the shield means shown in FIG. 20.

FIG. 23 is side elevation of a tubular probe, being a disposablecomponent of a fifth embodiment of an examination device of theinvention.

FIG. 24 is a longitudinal sectional elevation of a tubular probe andsealing means of the fifth embodiment including the probe of FIG. 23.

FIG. 25 is an end elevation of the embodiment of FIG. 24.

FIG. 26 is a view similar to FIG. 24 of a tubular probe and sealingmeans of a sixth embodiment of an examination device of the invention.

FIG. 27 is an end view of the probe and sealing means of FIG. 26.

FIG. 28 is a longitudinal sectional view of a backing piece appearing inFIG. 27.

FIG. 29 is front end view of the backing piece of FIG. 28.

FIG. 30 is a rear end view of the backing piece of FIG. 28.

DESCRIPTION OF PREFERRED EMBODIMENTS

FIGS. 1 to 8 depict a first embodiment of an examination device intendedfor use in the examination of the vagina. The device comprises anelongate tubular probe 1, a hand piece 2 and a closure member 3.

Tubular probe 1 is a colourless transparent plastic moulding which may,for example, be of acrylic having a bore 1A therethrough. For ease ofreference, tubular probe 1 can be described as having a first end 4 anda second end 5. A shield or guard means 6 of a larger diameter than thebody of the tubular probe 1 is located at the first end 4.

The shield 6 is a disc like member which may be integral with the firstend 4 of the tubular probe 1, in which case it is formed of the samematerial as the tubular probe 1, or it may be a separate member which issecured to the tubular probe 1. The shield 6 has a front surface 6Awhich is adapted to sealing engage tissue surrounding the body cavityopening to be examined. The diameter of the shield 6 is such as toengage tissue externally of the opening.

The hand piece 2 has a support sleeve 7 integral therewith, and containsa light source (not shown) therein. In this embodiment the handle isconnected to a transformer (light box) 8 which provides a low voltagepower source of say 3-12 volts to power the light source containedwithin the handle 2. Alternatively, self-contained batteries may beused. The sleeve 7 has a bore 15 therethrough which is adapted to allowthe tubular probe 1 to be removably fitted therein in such a manner thatthe shield 6 at the first end 4 of the tubular probe 1 is at the frontof hand piece 2, as shown in FIG. 1. When fitted, the front end 17 ofthe sleeve 7 is seated within the annular recess 18 of the tubular probe1.

The closure 3, has an eyepiece member 9 projecting from a sleeve portion10, and is adapted to sealingly engage over second end 5 of the tubularprobe 1. A bore surface 11 of sleeve portion 10 contacts the outersurface 12 of tubular probe 1 when closure 3 is in engagement therewith.Closure means 3 has an opening 13 adapted to be connected to one end ofan air supply means (not shown) which may be a manually operateddilation bulb which allows air to be pumped into a bore of the closure 3and into a bore of tubular probe 1. Closure 3 also has a sealable entryport 14 for insertion of a surgical implement or sampling device throughthe closure 3 and the tubular probe 1. When a surgical implement is notbeing used in conjunction with the device, the port 14 is sealed by aplug (not shown).

The examination device is usually supplied to a user as the threeseparate unassembled components of the tubular probe 1, hand piece 2 andclosure 3. The device may be assembled for use by attaching the tubularprobe 1 to the hand piece 2 by inserting the elongate tubular probe 1through the bore 15 of the sleeve 7. The closure 3 is then fitted to thesecond end of tubular probe 1.

In this embodiment of the device, once the components have beenassembled the shield 6 of the tubular probe 1 is at the front end of theexamination device. A physician wishing to examine a vagina through aspeculum, may bring the first end 4 of tubular probe 1 towards theopening of the vagina. The physician utilises the eyepiece 9, whichincorporates a magnification means, to view the vagina through thedevice. Light from the light source contained within handle 2 isprojected through the sleeve 7 and is transmitted through the colourlesstransparent plastic of tubular probe 1, thereby providing a light beamprojected into the vagina being examined. In the present embodiment acamera 16 is shown fitted to the eyepiece 9, in order to allow thephysician to take a record of the examination. It should however beunderstood that the device can be used without the camera 16 beingfitted, and in this instance the physician would be viewing directlyinto the eyepiece 9.

The surgical entry port 14 in closure member 3 allows for samplingdevices or surgical instruments to be passed through the device and intothe vagina for taking samples or conducting minor surgery. An advantageof such an arrangement is that the physician therefore can manipulatesuch sampling or surgical devices from the rear of the device andhis/her hands do not block the field of vision, as is sometimes the casewhen using known colposcopes. Furthermore, the examining device is easyto manipulate and can be readily packed away in a small case forportability. Where surgical and sampling devices are to be passedthrough port 14, a liner (not shown) of a disposable type may be fittedto port 14, to prevent contamination of closure means 3.

The tubular probe 1 is preferably a disposable item which may besupplied in a sterile package for use by a physician at the time ofinspection. The disc like shield 6 has the purpose of providing a shieldbetween the area being examined and that of the hand piece 2 and closure3 in order to prevent contamination of the latter components. It will beunderstood that the shield means 6 may differ in configuration to thatshown in FIG. 1 and may be of a larger diameter, and may for instancehave a different shape such as a dome or cup like configuration, asdiscussed in later embodiments.

It should also be understood that a probe tip (not shown) may be fittedto the first end 4 of tubular probe 1, or alternatively may be integralwith the tubular probe.

FIG. 9 depicts a second embodiment of an examination device intended foruse in the examination of the vagina. It has a number of like componentsto that of the first embodiment and such like components of the secondembodiment have been numbered with the same reference numerals as usedfor the first embodiment.

The second embodiment of the examination device comprises an elongatetubular probe 1, a hand piece 2 and a closure member 3. The maindifference between the second embodiment and that of the firstembodiment, is that the disc like shield 6 is replaced by a shield 26which is cup-shaped and is spaced from the first end 4 of the tubularprobe 1. The cup-shaped shield 26 provides enhanced shielding of thesleeve 7 of the hand piece 2, and additionally allows for theexamination device to be utilised as a speculum, with the portion ofelongate tubular probe 1 located between the first end 4 and shieldmeans 26 forming a probe 20 for insertion into a vagina

In use, the probe 20, is inserted into a vagina and passes through thePC muscles, with the base 21 of the shield 26 pushed against theperiphery of the vaginal opening. The base 21 of the shield 26 isprovided with a number of annular ribs 22. Once the probe 20 has beeninserted into the vagina and the ribs 22 of the shield 26 have beenpushed up against the periphery of the vaginal opening, air can beintroduced through the bore of the tubular probe 1 and into the innercavity of the vagina by means of an air supply means connected toopening 13 on the closure 3. A delivery tube 23, which may be connectedto a manually operated dilation bulb (not shown), or alternatively to afoot actuated dilation bulb, is used to deliver air to the opening 13.By holding the shield 26 against the outer body at the vaginal opening,a seal is maintained to ensure that the air introduced into the innercavity of the vagina does not escape. This enables the user to inspectthe vagina through eye piece 9. The inspection of the inner cavity ofthe vagina is possible as the closure means 3 incorporates eye piece 9with a line of sight extending through the bore of the tubular probe 1.

The design of this second embodiment of the present invention, is suchthat the shield means 26 allows for the examination device to be movedat the entrance of the vagina to conduct a thorough examination of theinner cavity, which is assisted by having air expand the vagina.

FIG. 10 illustrates a third embodiment of a examination device inaccordance with the invention. In this embodiment, first end 4 isoblique to the longitudinal axis of the tubular probe, such that thelight being transmitted therefrom can be positionally controlled byrotating the examination device whilst probe 20 is inserted in the innercavity of the vagina.

It will be understood that the dimensions of the tubular probe 1 and ofthe shield 26 may vary in accordance with needs of different patientsand different types of examination. Thus, both the diameter of theshield 26 and the length of the probe portion 20 will change. In afourth embodiment as shown in FIG. 11, an examination device similar tothat of the second embodiment is shown, the main difference being theprobe 20 is longer. In situations where a tissue or culture sample is tobe taken from the cervix the user, having located the cervix, may pressthe free end 4 of tubular probe 1 of this fourth embodiment against thecervix, then remove closure 3. A sample may then be obtained byinserting a spatula through the tubular probe 1 to scrap the necessarycellular material. Alternatively, a spatula or cervical brush (notshown) may be inserted into the bore of the tubular probe 1 prior toinsertion of the probe 20 of the examination device into the innercavity of the vagina. The spatula or cervical brush may be manipulatedby a manipulatable end which passes through the port 14 in the closure3. A ring 27 (see FIG. 12) at the first end 4 of the tubular probe ofthis fourth embodiment is provided as an abutment for the head of thespatula (or cervical brush) whilst the probe and spatula are insertedinto the vagina.

FIGS. 12 and 13 shown an enlarged detail of the tubular probe 1 andshield 26 of the fourth embodiment. It will be understood that these maybe separate components made of disposable synthetic plastic material andmay be assembled so that the shield 26 sealing engages on the tubularprobe 1. The tubular probe 1 of the second and third embodiments areshown in enlarged detail in FIGS. 14-16 and FIGS. 17-19, respectively,whilst the cup-shaped shield 26 is shown in FIGS. 20-22. It should beunderstood that the shield 26 of FIG. 20 may be fitted and secured toeither of the tubular probes 1 shown in FIG. 15 or 18 by means of aMorse taper.

The tubular probe shown in FIGS. 23 to 25 is essentially the same as theprobe of the earlier described embodiments except for the presence of acircumferential abutment 30 thereon. The portion 31 of the probe to therear of the abutment 30 is configured to receive a hand piece and aclosure in the same manner as in the previous embodiments. Similarly,the probe portion 32 ahead of the abutment 30 is adapted to enter a bodycavity in such a manner and for the same purpose as the tubular probesof the preceding embodiments.

The abutment 30 acts as a locating shoulder for a combined shield andsealing element 33. The element 33 comprises a domed, self supporting,annular layer of foamed synthetic plastics material, such aspolyethylene which is sufficiently resilient to be relatively soft tothe touch but with sufficient stiffness to be able to act as a seal.

In the embodiment illustrated in FIGS. 26 to 30, the shield comprises arelatively stiff backing element 34 comprising a tubular core 35 adaptedto engage as sleeve on the front end portion 32 of the tubular probe.The tubular core 35 contacts the abutment 30 to locate the core andbacking element in position. The element includes a flared skirt 36extending from the forward end of the core 35.

The backing element 34 supports the centre portion of a L-shaped annularshield 37 which sealingly engages the surface of the tubular probe atthe forward end portion 32 in front of the tubular core 35. The shield37 is preferably moulded of a foamed synthetic plastics material havinga resiliency to be relatively soft to the touch but being sufficientlystiff as to be self-supporting outwardly of the backing element 34 so asto be able to be seal against body tissue surrounding the orifice intowhich the probe is inserted. If desired, sealing ribs or the like may bemoulded into the front surface of the element 37 to assist the sealingaction when engaged with the body tissue. The close engagement of theelement 37 with the forward end 32 of the probe ensures an effectiveseal between the element 37 and the probe as well as frictionallyretaining the shield in place in use.

An advantage of the described embodiments of the present invention isthat the examination device can be used in conjunction with a knowndilating speculum for inspection of the vagina, or by itself, as in thesecond, third and fourth embodiments to conduct an examination of thevagina by introducing air therein. When used by itself, without use ofdilating speculum, a further advantage is that the risk of contaminationof the cervix by a lubricant such as is typically used with speculums,is substantially reduced.

When an examination and/or surgical procedure is complete, the tubularprobe 1, the shield 6, 26 and any other disposable component may bediscarded, and new disposable components used for a next examination.

It will be apparent that while the tubular probe 1, is described asbeing formed from a plastics material such as acrylic, which issubstantially rigid, it may also manufactured from a plastics materialwhich has a greater flexibility, or from some other material such assilicone rubber or the like.

In other shown variations of the second, third and fourth embodiments,the ribs 22 on the shield 26 may be replaced by other forms of surfacedeformations which act as a seal when engaged with body tissue.Alternatively, an elasticised annular seal member, possibly of siliconerubber or the like, may be fitted against the base 21 to provide theseal. Such a seal member may of solid or resilient material or,alternatively, may be in the nature of a pliable bag having an enclosedcavity containing fluid such as air or water.

In another embodiment not illustrated the cup-shaped shield 26 as shownin the second, third and fourth embodiments may be reversed on thetubular probe 1 such that, in use, the open end of the cup engages withthe tissue surrounding the opening of the body cavity when the probe 20is inserted thereinto.

The examination device of the above described embodiments may besupported by a stand or other support member when in use. Preferably thehand piece of the device would engage with the stand.

Although described above primarily with reference to examination of thevagina, it will be appreciated that the examination device according tothe invention, but modified if necessary in respect of the relative sizeand shape of the tubular probe and the shield, may be used for internalexamination of other body cavities, for example the lower bowel, ear,nose or throat or, for veterinary use, the body cavities of animals.

In other embodiments the ring shaped abutment 30 may be replaced by aplurality of spaced abutment lugs or may be formed as a shoulder betweendifferent diameter portions 31 and 32 of the probe.

What is claimed is:
 1. An examination device for examining the interiorof a body cavity, said device including a tubular probe having a first,forward end and a second, rearward end, the tubular probe being adaptedto be engaged with a hand piece by which the probe is manipulated, and asealing shield on said tubular probe adapted to shield said hand piecefrom contact with tissues surrounding the body cavity and furtheradapted to act as a seal for the body cavity to reduce egress of fluidtherefrom.
 2. A device according to claim 1 wherein a closure means isattached to the second end of the tubular member, the closure meansincluding an eye-piece and being so disposed on the tubular member as toprovide a line of sight therethrough.
 3. A device according to claim 1wherein said sealing shield is disc-shaped.
 4. A device according toclaim 1 wherein said sealing shield is cup-shaped.
 5. A device accordingto claim 1 wherein said sealing shield is dome-shaped.
 6. A deviceaccording to claim 1 wherein said sealing shield is bell-shaped.
 7. Adevice according to claim 1 wherein said sealing shield has coaxialcircular ribs or projections formed on a front surface.
 8. A deviceaccording to claim 1 wherein said shield is formed of a foamed syntheticplastics material.